This is a prospective, randomized, double-blinded, sham-controlled trial conducted to investigate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) combined with cervical epidural injection in the treatment of cervical radiculopathy. A total of 80 subjects will be enrolled and randomly assigned (1:1) to either the experimental group or the control group. The primary outcome measure is the proportion of subjects with a ≥50% reduction in the Numerical Rating Scale (NRS) pain score at discharge. Secondary outcomes include pain intensity, pain interference, psychological status, sleep quality, physical disability, and autonomic function measurements. Adverse events will be monitored throughout the study.
Age between 18 and 85 years old.
Body Mass Index (BMI) between 18 and 35 kg/m².
American Society of Anesthesiologists (ASA) physical status I to III.
Diagnosed with cervical radiculopathy, scheduled for selective cervical epidural injection.
Arrhythmia requiring treatment, severe bradycardia, or postural orthostatic tachycardia syndrome.
Neuromuscular disorders or auricular dermatitis.
Cervical fracture, tumor, tuberculosis, or active infection confirmed by imaging.
Contraindications to vagus nerve stimulation: carotid sinus hypersensitivity, bilateral carotid artery stenosis.
Parallel
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
BehavioralPreoperative non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) administered for 3 consecutive days, 1-2 hours daily. Electrode placed on the left cymba conchae. Parameters: 30Hz frequency, 200μs pulse width, current titrated to patient tolerance (max 50mA).
Cervical Epidural Injection
Procedure/SurgeryStandard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine.
Proportion of Participants Achieving ≥50% Reduction in NRS Pain Score
The proportion of participants achieving a ≥50% reduction in Numerical Rating Scale (NRS) pain score from baseline to the post-procedure day 1 assessment.
Preoperative, 24 hours postoperatively, and post-procedure day 1
Changes in Brief Pain Inventory (BPI) scores, including worst, least, average, and current pain intensity, as well as pain interference with daily activities, measured from preoperative baseline to 24 hours postoperatively and post-procedure day 1.
Hospital Anxiety and Depression Scale (HADS) Score Changes
Changes in Hospital Anxiety and Depression Scale (HADS) scores, including anxiety and depression subscales, measured from the preoperative baseline to post-procedure day 1 to evaluate psychological status.
Insomnia Severity Index (ISI) Score Changes
Changes in Insomnia Severity Index (ISI) scores, measured from the preoperative baseline to post-procedure day 1, to evaluate improvements in sleep quality.
Neck Disability Index (NDI) Score Changes
Changes in Neck Disability Index (NDI) scores, measured from the preoperative baseline to post-procedure day 1, to evaluate improvements in neck function and daily activity ability.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
